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Clinical Trials/EUCTR2013-000653-42-BE
EUCTR2013-000653-42-BE
Active, not recruiting
Not Applicable

Feasibility study of the (intravenously injected) ICG imaging of tumoral implants in patients with peritoneal carcinomatosis from colorectal cancer

Jules Bordet Institute0 sitesFebruary 27, 2013
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DrugsICG Pulsion

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Jules Bordet Institute
Status
Active, not recruiting
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 27, 2013
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Eligibility Criteria

Inclusion Criteria

  • •\- Patients (either newly diagnosed, or relapsing) with peritoneal carcinomatosis from histo\-pathologically proven colorectal carcinoma who are candidate for open” surgery, either after neo\-adjuvant chemotherapy (80\-90% of the cases), or in first intent”.
  • •\- Informed consent form signed.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 10
  • •F.1\.3 Elderly (\>\=65 years) no
  • •F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • •\- Age less than18 years old.
  • •\- Inability to give informed consent.
  • •\- History of allergy or hypersensitivity against the investigational product (its active substance or ingredients), to iodine or to shellfish.
  • •\- Apparent hyperthyroidism, autonomous thyroid adenoma, unifocal, multifocal or dissemi\-nated autonomy of the thyroid gland.
  • •\- Documented coronary disease.
  • •\- Advanced renal impairment (creatinine \> 1,5mg/dl).
  • •\- During the 2 weeks before the enrolment, concurrent medication which reduces or increases the extinction of ICG (i.e. anticonvulsants, haloperidol and Heparin).
  • •\- Pregnancy, breastfeeding

Outcomes

Primary Outcomes

Not specified

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